The purpose of this clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24 patients may be enrolled in this study at the Mitchell Cancer Institute. All patients enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin, and Cyclophosphamide.

IV administered over 30 minutes. The study will test four dose levels.

Other Name: Abraxane

Drug: doxorubicin

50 mg/m2 every 3 weeks

Other Name: Adriamycin

Drug: cyclophosphamide

500 mg/m2 given every 3 weeks

Detailed Description:

This is a single center, open phase I dose escalation study. This study will assess the highest tolerable dose of nab-paclitaxel (Abraxane) in combination with doxorubicin (Adriamycin) and cyclophosphamide in patients with stages II-III breast cancer in the neoadjuvant setting. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination. Up to 24 patients will be enrolled.

The study will test four dose levels of Abraxane as described in Table 2, with fixed dose of doxorubicin (50 mg/m2 weekly) and cyclophosphamide (500 mg/m2). For each cycle, Abraxane will be administered based on the dose schedule in Table 2. Adriamycin and Cyclophosphamide will be given on day 1 and day 22 of each cycle. Each cycle will be repeated every 6 weeks. The study will enroll patients with stages II-III, Her-2 negative breast cancer with no prior therapy. Patients will be treated for 3 six-week cycles, for a total of 18 weeks.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically or cytologically proven adenocarcinoma of the breast stages II-III, according to the AJCC Staging Manual, 6th Edition, 2002

ANC greater than or equal to 1,500/mm3; platelet greater than or equal to 100,000/mm3; hemoglobin greater than or equal to 9 gm/dL

Serum bilirubin levels less than or equal to 1.5 mg/dL

Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 X upper limit of normal, alkaline phosphatase less than or equal to 2.5 X upper limit of normal.

Serum creatinine levels less than or equal to 1.5 mg/dL

Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. Appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator.

Female, greater than or equal to 19 years of age and any race.

Exclusion Criteria:

Evidence of metastatic disease

Concurrent therapy with any other non-protocol anti-cancer therapy

Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators

The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications

Pregnancy or breast feeding

A history of a severe hypersensitivity reaction to nab-paclitaxel.

Any reason why, in the opinion of the investigator, the patient should not participate.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090128